- Responsible for the line-management of individuals within a team as well as a project team.
- Manage direct reports to ensure staff training records are up to date.
- Responsible for managing performance reviews and issues of direct reports.
- May manage individuals across multiple teams and will take on responsibility for cross department projects.
- Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.).
- Escalate issues to Senior Management as needed
- Ability to proactively problem solve
- Participate in department improvement initiatives (identification, implementation)
- Assist with development and continual improvement of departmental training curriculum
- Provide input on junior staff development
- Participate in interview process for new/replacement staff
- Act as a support person in the preparation of study-specific Safety Monitoring Plans for Managers, DSPMs
- Assist in mentoring junior PV&DSS Managers and DSPMs within the team
- Take lead on ad hoc strategic initiatives
- May lead or assist with the management of PV&DSS concerning project allocation and resourcing.
- Act as primary team lead for 1-2 projects
- Oversee individuals who manage receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but not limited to:.
- Oversee the maintenance of files regarding adverse event reporting requirements in assigned countries.
- Lead the generation and review of SOPs, Work Instructions etc.
- Responsible for SOP implementation within assigned team.
- Assist in developing Operational metrics measuring PV&DSS’ overall performance.
- Manage the recruitment of new staff to PV&DSS.
- Build and maintain good PV&DSS relationships across functional units.
- Demonstrate role specific Competencies on consistent basis.
- Demonstrate company Values on consistent basis.
- Financial authority as it relates to projects.
- Any other duties as assigned by management.
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
- At least 4 years line management and/or project management experience.
- Industry experience of which 10 years is relevant to pharmacovigilance/drug safety knowledge.
- Good verbal, written and presentation skills.
- Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
- Work collaboratively with PV&DSS Management’s team
- Strong Leadership capabilities
- Excellent Communication
- Overall departmental resource
- Client service focus
- Ability to multitask and prioritize
- High degree of accuracy with attention to detail.
- Ensure client and global regulatory compliance
- Will present and share useful business information across departments and functions
- Anticipate/identify problems and takes appropriate action to correct.
- Knowledge of medical and drug terminology
- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
- Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products
- Knowledge of Medical Device Reporting desirable
- Knowledge of aggregate reporting
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
- Financially intuitive
- Proficient knowledge of ICH guidelines.
- Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
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